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Virtual Work Space May Help FDA Speed Gene Therapy Applications

June 14, 2021, 9:59 PM

The regenerative medicine industry may see its review times shortened at the FDA as the agency takes advantage of the virtual work environments to bring in experts temporarily.

“We will be doing our best to staff up as much as we possibly can as quickly as we can,” Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said Monday at the Biotechnology Innovation Organization’s annual meeting. But he still wants the agency to move more quickly.

With more than 900 cell and gene therapy products in the pipeline, CBER will need to expand its ...

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